Neurophet Achieves FDA Clearance for Advanced MS MRI Analysis Through Neurophet AQUA Software

Neurophet Obtains FDA 510(k) Clearance for Neurophet AQUA

Neurophet, a leading artificial intelligence (AI) company specializing in brain disease diagnostics, has made a significant leap forward with its software, Neurophet AQUA. Announced on November 25, 2024, the company received FDA 510(k) clearance for its new functionality focused on analyzing multiple sclerosis (MS) through MRI scans.

This latest approval builds on an earlier clearance from May, which authorized the software's capabilities for brain atrophy analysis using T1-weighted MRI images. The expansion now includes advanced analytical features for assessing MS, as well as investigating white matter hyperintensities (WMH) utilizing T2-FLAIR MRI images.

Neurophet AQUA has been designed to harness AI technology in the interpretation of MRI scans, facilitating quick and detailed analyses of various neurodegenerative diseases, including Alzheimer's. The software is capable of delivering rapid image segmentation and analytical results in just five minutes, providing healthcare professionals with crucial information in real-time.

The newly incorporated MS analysis technology in Neurophet AQUA quantifies lesions and tracks structural changes in the brain, allowing for accurate measurements of lesion count, volume, and progression. A particularly noteworthy feature is the software's robust segmentation capabilities across both 2D and 3D imaging modalities of T2-FLAIR MRI, which can be utilized at both 1.5T and 3.0T MRI strengths. The volumetric capabilities enable detailed analysis of brain regions without the need for 3D T1 imaging, enhancing diagnostic precision.

Multiple sclerosis is an autoimmune disease characterized by the demyelination of the central nervous system, impacting the brain, spinal cord, and optic nerves. Commonly diagnosed in individuals aged between 20 and 40, MS affects more women than men and is especially prevalent in Caucasian populations in North America and Europe, while being less common among Asian and African American groups.

MRI stands as the gold standard for MS diagnosis and is typically accompanied by blood tests and cerebrospinal fluid analysis. Given the recurrence tendencies of MS, continuous MRI monitoring is vital to track disease prognosis.

Jake Junkil Been, Co-CEO of Neurophet, emphasized the importance of MRI in MS diagnosis, stating, "The McDonald criteria for MS diagnosis specifically requires MRI confirmation of lesions that are disseminated in space and time. The advanced capabilities of Neurophet AQUA significantly improve the efficiency and convenience for healthcare providers, making it an essential tool in both diagnostics and prognostics."

With FDA clearance in hand, Neurophet aims to strengthen its presence internationally, particularly in regions such as the U.S. and Europe, where MS prevalence is high. The company is determined to leverage this milestone to expand and improve healthcare delivery, emphasizing its commitment to utilizing AI technologies to enhance the understanding and treatment of brain diseases.

Founded in 2016 by co-CEOs Jake Junkil Been and Donghyeon Kim, Neurophet is committed to pioneering solutions for brain-related illnesses. The company not only develops software like Neurophet AQUA but also focuses on a range of diagnostic support tools, treatment guides, and devices tailored to brain diseases. Their vision is clear: to improve patient outcomes through innovative technology and continued research in the field of neuroscience. As they embark on their next steps to grow globally, Neurophet is poised to make meaningful impacts on brain health and medical science through advancements in AI and technology.